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FDA 510(k)

MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX

K-Number: K100786 · 2010-08-13

ApplicantBsd Medical Corp.
Decision Date2010-08-13
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX is the device name listed in this FDA 510(k) record. The listed applicant is Bsd Medical Corp.. It received FDA 510(k) clearance on 2010-08-13 under 510(k) number K100786. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX?

MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX is a medical device that received FDA 510(k) clearance on 2010-08-13. The listed applicant is Bsd Medical Corp.. The 510(k) number is K100786.

When did MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX receive FDA 510(k) clearance?

MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX received FDA 510(k) clearance on 2010-08-13, under 510(k) number K100786.

Who is the listed applicant for MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX?

The FDA 510(k) record lists Bsd Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX?

The FDA product code for MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX is NEY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Bsd Medical Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K833158BSD-200

Related Devices (Code: NEY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.K253771Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)Nanjing Devin Medical Technology Co., Ltd.K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation LimitedK241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc.K241825Microwave Ablation AntennasCanyon Medical, Inc.K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)Varian Medical Systems, Inc.

Official Source

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